The Home Based Assessment will evaluate three in-home types of information gathering and determine how practical each method is. Second, it will find out if these three methods of gathering information can detect a change and a rate of change in both the volunteers’ daily living activities and their functional capabilities over time.

Criteria

normal mental function

aged 75 and older

able to live independently

fluent in English

willing to take multi-vitamins provided by the study

able to dial a telephone, have access to secure mail, possess minimal computer skills or a willingness to learn

Study Procedures

4 years

in-person screening assessment that includes a physical exam, a medical history, a memory assessment, and a neurological exam

Approximately 2.5 years from first subject enrolled - Approximately 1 year of enrollment and 82 weeks of study participation for each subject.

Description:

This study aims to evaluate the novel use of an agent (Immune Globulin Intravenous (Human), 10% [IGIV, 10%]ii) that is approved in the United States to treat various immunodeficiency and autoimmune disorders. IGIV is a biologic agent with anti-inflammatory and immunomodulating properties containing human immunoglobulin G (IgG) antibodies derived from the blood plasma of healthy donors. Specifically, IGIV contains antibodies that bind to oligomeric and fibrillar beta amyloid, thus supporting the rationale of studying IGIV as an agent for passive immunotherapy of AD. Passive immunization does not require the recipients to produce antibodies themselves and can thereby circumvent the problem of inadequate antibody generation by older individuals. Unlike active vaccination, T-cell activation is not required to realize the full therapeutic benefits of passive immunization; this may therefore reduce but not entirely eliminate the possibility of reactive inflammatory reactions like the meningoencephalitis experienced in the AN-1792 study. Passive immunization could therefore provide a safe and effective alternative to active vaccination for the treatment of elderly AD patients, thus providing a strong rationale for studying passive immunization with IGIV as a potential treatment for AD.

A maximum 42 day screening period followed by 24 weeks of treatment and a 28 week follow-up period, during which patients will not be receiving study medication. The estimated enrollment time is 18 months.

Description:

To assess the safety and tolerability of BMS-708163 in patients with prodromal Alzheimer’s Disease.

Alzheimer’s disease (AD) is a progressive neurodegenerative disease which begins with memory loss and progresses to include severe cognitive impairment, altered behavior, and decreased motor function. Recent data suggests that incipient AD can be identified with increasing sensitivity using cerebrospinal fluid biomarkers consistent with AD

The concept of defining prodromal AD using traditional mild cognitive impairment (MCI) criteria along with the presence of a biomarker associated with AD pathology is becoming increasingly accepted within the scientific community as a way of identifying patients with incipient AD. Identifying AD in the earliest phase of the disease process offers the opportunity to explore whether the use of potentially disease-modifying agents might alter the long-term course of the illness and prevent the neurodegenerative cascade associated with the disease. No drug therapy is currently indicated for prodromal AD.

Studying the effect of BMS-708163, a potentially disease modifying agent, earlier in the disease process may have greater impact in the delay of progression of the illness. For the purposes of this protocol, prodromal AD is defined as outpatients with: 1) MMSE scores between 24-30 (inclusive); 2) a memory complaint; 3) objective memory loss measured.

Requirements:

Age 45-90

Diagnosis of Mild Cognitive Impairment (not dementia)

Reliable study partner to accompany you to all visits

MMSE scores between 24 and 30 (inclusive)

Able to read and write in English

Stable health and medications

Contact:

Elizabeth Ortega, NP at 858-677-1567

Passive Immunization

(Amyloid antibody treatment for Alzheimer’s disease)

PI: James Brewer, MD, PhD

Passive Immunization is a Phase 3 study to evaluate the safety and effectiveness of an investigational drug, Bapineuzumab, for controlling progression of AD. Most current therapies for Alzheimer’s treat the symptoms associated with it and not the disease itself. Bapineuzumab is an antibody (a type of protein usually produced by white blood cells to destroy other substances) that may help to clear beta amyloid from the brain. Beta amyloid is a protein that accumulates in brain tissue to form plaques, which are believed to play a major role in the development of AD.

Bapineuzumab is given as a series (a total of 6) of intravenous infusions, delivering antibodies to beta-amyloid. This approach is called “passive immunization,” since the body is receiving the antibodies via the drug, rather than generating the antibodies itself. This drug is being tested in individuals with mild-to-moderate Alzheimer’s. Approximately 4,000 subjects at more than 350 sites worldwide (include 200 sites in the United States and Canada) are expected to participate. Study participants will be randomly assigned to receive Bapineuzumab, or a placebo, so there is a 60 % chance of receiving Bapineuzumab and a 40 % chance of receiving a placebo.

The clinical assessments visits will take place at the Alzheimer’s Disease Research Center. The infusion visits will take place at the General Clinical Research Center at the UCSD Medical Center in Hillcrest. The infusion visits will occur every 13 weeks.